Vitamin E beats drug treatment for NASH

In a presentation at the 60th Annual Meeting of the American Association for the Study of Liver Diseases held October 30 to November 3, 2009 in Boston, Arun Sanyal, MD of the Virginia Commonwealth University’s Department of Internal Medicine reported the results of a double-blind, placebo-controlled trial which found that vitamin E was more successful than the antidiabetic drug pioglitazone at treating nonalcoholic steatohepatitis (NASH). Nonalcoholic steatohepatitis is a progressive liver disease associated with fatty liver, insulin resistance and obesity. An estimated 3 to 4 percent of Americans have NASH, which progresses to cirrhosis in 15 to 20 percent of the cases, due to inflammation. The disease currently has no established treatment.

The study included 247 nondiabetic patients whose liver biopsies had confirmed NASH within six months of the trial. Participants were randomized to receive 30 milligrams per day of the insulin-sensitizing drug pioglitazone, 800 international units per day vitamin E, or a placebo for 96 weeks.

Liver biopsies were performed on 90 percent of the participants at the end of the trial. While nonalcoholic fatty liver disease activity scores, which assess steatosis, inflammation and the presence of ballooned liver cells, improved in 19 percent of the placebo patients, 34 percent of those who received pioglitazone and 43 percent of those who received vitamin E had improved scores, with no worsening of fibrosis. Serum alanine aminotransferase (ALT), which detects liver injury, improved in both the vitamin E and drug group, however, treatment with pioglitazone resulted in greater weight gain compared to vitamin E or the placebo.

The trial is the first large study to demonstrate a benefit for vitamin E in nonalcoholic steatohepatitis treatment. "Not only did vitamin E improve liver function in 40 percent of the patients treated with it, but the specific type of vitamin E used in the study is inexpensive, readily available, and caused no side effects in patients who participated in the study," Dr Sanyal remarked.

Steatosis (or fatty liver) is a common finding in biopsy of the human liver. Fatty liver is a condition in which fat accumulates within the liver cells (hepatocytes) without causing any specific symptoms. (Fatty liver is defined as either more than 5% of cells containing fat droplets or total lipid exceeding 5% of liver weight.)

Fatty liver is usually a long-standing chronic condition, occurring in association with a wide range of diseases--exposure to poisonous and toxic substances, taking certain drugs, and drug abuse (injecting recreational drugs) (Glanz 1996)--although in clinical practice, the majority of cases are the result of excessive use of alcohol, diabetes, and obesity. Less common are occurrences of acute fatty liver during pregnancy or as a response to the administration of tetracyclines, acetaminophen, prescription drugs, and toxins.

Our understanding of the fatty liver condition has advanced considerably. At one time, fatty liver was believed to be a benign, reversible condition. However, clinical studies now demonstrate that fatty liver, whether from alcoholic or nonalcoholic origin, can lead to inflammation, cell death, and fibrosis (steatohepatitis), perhaps even progression to cirrhosis. Cirrhosis is the irreversible end result of fibrous scarring, a response by the liver to a variety of long-standing inflammatory, toxic, metabolic, and congestive damage processes.

Obesity is among the causes for nonalcoholic steatohepatitis (NASH) and is considered to be the most common cause. There is evidence to suggest that liver disease can actually be considered to be a complication of obesity. However, no major prospective longitudinal studies of NASH have been carried out. Generally, it seems that the risk of progression to cirrhosis is low for nonobese individuals, but significant among obese individuals. Unfortunately, there is also no predictable correlation between symptoms (or lack of them), abnormality of liver function tests, and severity of liver tissue damage.

Antioxidants afford protection to the liver from the damaging effects of free radicals produced from environmental toxins.

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